AccessGUDID - DEVICE: Atlanta Healthcare Services Ocudrape (10851736007996)

GUDID

Device Identifier (DI) Information

Brand Name: Atlanta Healthcare Services Ocudrape
Version or Model: 10851736007996
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OES5702CS
Company Name: ATLANTA HEALTHCARE SERVICES, INC.

Primary DI Number: 10851736007996
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 130599421 *Terms of Use

Device Description: Eye Shield, Polycarbonate, Optical Grade for Clarity & Safety, BPA Free, 100 / BOX, Non Sterile

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65733	Postsurgical eye shield, vented	A device designed to be worn over the eye to protect the eye following ophthalmic surgery; some types may in addition be used following injury/trauma. It is designed as a transparent or opaque dome with vent holes to allow air to circulate around the eye; it may be self-adhesive, or fixed by a strap or an adhesive dressing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f11f8bbe-bbbc-4801-a3b0-5a4378c1f379
Public Version Date: June 19, 2024
Public Version Number: 2
DI Record Publish Date: July 13, 2023